[Federal Register Volume 72, Number 76 (Friday, April 20, 2007)]
[Notices]
[Pages 19937-19938]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-7591]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


National Vaccine Injury Compensation Program: Addition of 
Meningococcal and Human Papillomavirus (HPV) Vaccines to the Vaccine 
Injury Table

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice.

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SUMMARY: Through this notice, the Secretary announces that 
meningococcal (conjugate and polysaccharide) and human papillomavirus 
(HPV) vaccines are covered vaccines under the National Vaccine Injury 
Compensation Program (VICP), which provides a system of no-fault 
compensation for certain individuals who have been injured by covered 
childhood vaccines. This notice serves to include meningococcal and HPV 
vaccines as covered vaccines under Category XIV (new vaccines) of the 
Vaccine Injury Table (Table), which lists the vaccines covered under 
the VICP. This notice ensures that petitioners may file petitions 
relating to meningococcal and HPV vaccines with the VICP even before 
such vaccines are added as separate and distinct categories to the 
Table through rulemaking.

DATES: This notice is effective on April 20, 2007. As described below, 
meningococcal and HPV vaccines are covered under the VICP as of 
February 1, 2007.

FOR FURTHER INFORMATION CONTACT: Geoffrey Evans, M.D., Division 
Director, Division of Vaccine Injury Compensation, Healthcare Systems 
Bureau, Health Resources and Services Administration, Parklawn 
Building, Room 11C-26, 5600 Fishers Lane, Rockville, Maryland 20857; 
telephone number (301) 443-6593.

SUPPLEMENTARY INFORMATION: The statute authorizing the VICP provides 
for the inclusion of additional vaccines in the VICP when they are 
recommended by the Centers for Disease Control and Prevention (CDC) for 
routine administration to children. See section 2114(e)(2) of the 
Public Health Service (PHS) Act, 42 U.S.C. 300aa-14(e)(2). Consistent 
with section 13632(a)(3) of Pub. L. 103-66, the regulations governing 
the VICP provide that such vaccines will be included as covered 
vaccines in the Table as of the effective date of an excise tax to 
provide funds for the payment of compensation with respect to such 
vaccines (42 CFR 100.3(c)(5)).
    The two prerequisites for adding meningococcal (conjugate and 
polysaccharide) and HPV vaccines to the VICP as covered vaccines as 
well as to the Table have been satisfied. In its May 27, 2005, issue of 
the Morbidity and Mortality Weekly Report (MMWR), the CDC published its 
recommendation that meningococcal conjugate vaccines be routinely 
administered to young adolescents at the pre-adolescent visit (11-12 
years olds). Additionally, for those individuals who have not 
previously received the meningococcal conjugate vaccine, the CDC has 
recommended vaccination before high school entry to further reduce the 
incidence of meningococcal disease in adolescents and young adults. The 
CDC also recommends routine vaccination for college freshmen who live 
in dormitories because they are at higher risk for meningococcal 
disease when compared with same aged cohorts. The use of meningococcal 
conjugate vaccine is preferred among persons aged 11-55 years. If 
meningococcal conjugate vaccine is unavailable, meningococcal 
polysaccharide vaccine is an acceptable alternative for persons aged 
11-55 years. Meningococcal polysaccharide vaccine is also recommended 
for children aged 2-10 years and persons aged 55 years and older who 
are at increased risk for meningococcal disease.
    In its March 23, 2007, issue of the MMWR, the CDC published its 
recommendation that the HPV vaccine be routinely administered to 
females aged 11-12 years. The HPV vaccine can be administered to 
females as young as 9 years. Vaccination is recommended for females 
aged 13-26 years who have not previously received the vaccine or who 
have not completed the full series.
    On December 20, 2006, the excise tax legislation for meningococcal 
and HPV vaccines was enacted by Pub. L. 109-432, the ``Tax Relief and 
Health Care Act of 2006 (the Act).'' Section 408 of this Act adds all 
meningococcal and

[[Page 19938]]

HPV vaccines to section 4132(a)(1) of the Internal Revenue Code of 
1986, as amended, which defines all taxable vaccines.
    Under the regulations governing the VICP, Category XIV of the Table 
specifies that ``[a]ny new vaccine recommended by the [CDC] for routine 
administration to children, after publication by the Secretary of a 
notice of coverage'' is a covered vaccine under the Table (42 CFR 
100.3(a), Item XIV). As explained above, the CDC issued its 
recommendation. This notice serves to satisfy the regulation's 
publication requirement. Through this notice, meningococcal and HPV 
vaccines are included as covered vaccines under Category XIV of the 
Table.
    Under section 2114(e) of the PHS Act, as amended by section 
13632(a) of the Omnibus Budget Reconciliation Act of 1993, coverage for 
a vaccine recommended by the CDC for routine administration to children 
shall take effect upon the effective date of the tax enacted to provide 
funds for compensation with respect to the vaccine included as a 
covered vaccine in the Table. Under section 408 of the Tax Relief and 
Health Care Act of 2006, the effective date for the excise taxes 
enacted for meningococcal vaccines against meningococcal disease and 
the HPV vaccine against HPV disease and infection applies to sale and 
uses on or after ``the first day of the first month which begins more 
than 4 weeks after the date of the enactment of this Act.'' It further 
provides that if the vaccines were sold on or before the effective date 
of the excise tax, but delivered after this date, the delivery date of 
such vaccines shall be considered the sale date.
    Under this authorizing statutory language, the effective date for 
coverage of the meningococcal and HPV vaccines under the VICP is 
February 1, 2007. Thus, meningococcal and HPV vaccines are included as 
covered vaccines under Category XIV of the Table as of February 1, 
2007. Petitioners may file petitions related to meningococcal and HPV 
vaccines as of February 1, 2007.
    Petitions filed concerning vaccine-related injuries or deaths 
associated with meningococcal and HPV vaccines must be filed within the 
applicable statute of limitations. The filing limitations applicable to 
petitions filed with the VICP are set out in section 2116(a) of the PHS 
Act (42 U.S.C. 300aa-16(a)). Persons who may be eligible must file 
petitions within: three (3) years from the first symptom or 
manifestation of onset of an injury or of the significant aggravation 
of the injury; or two (2) years from the date of a vaccine-related 
death and four (4) years after the start of the first symptom of the 
vaccine-related injury from which the death occurred.
    In addition, section 2116(b) of the PHS Act lays out specific 
exceptions to these statutes of limitations that apply when the effect 
of a revision to the Table makes a previously ineligible person 
eligible to receive compensation or when an eligible person's 
likelihood of obtaining compensation significantly increases. Under 
this provision, persons who may be eligible to file petitions based on 
the addition of a new vaccine under Category XIV of the Table may file 
a petition for compensation not later than 2 years after the effective 
date of the revision if the injury or death occurred not more than 8 
years before the effective date of the revision of the Table (42 U.S.C. 
300aa-16(b)). Thus, persons whose petitions may not be timely under the 
limitations periods described in section 2116(a) of the PHS Act, may 
still file petitions concerning vaccine-related injuries or deaths 
associated with meningococcal and HPV vaccines until February 2, 2009, 
as long as the vaccine-related injury or death occurred on or after 
February 1, 1999 (8 years prior to the effective date of the addition 
that included meningococcal vaccines and HPV as covered vaccines). 
Although two years from the date of February 1, 2007, would be February 
1, 2009, under the current Rules of the United States Court of Federal 
Claims, the deadline under section 2116(b) of the PHS Act would be 
February 2, 2009, because February 1, 2009, falls on a Sunday.
    The Secretary plans to amend the Table through the rulemaking 
process by including meningococcal and HPV vaccines as separate 
categories of vaccines in the Table. February 1, 2007, will remain the 
applicable effective date when the Secretary makes a corresponding 
amendment to add meningococcal and HPV vaccines as separate categories 
on the Table through rulemaking.

    Dated: April 16, 2007.
Elizabeth M. Duke,
Administrator.
 [FR Doc. E7-7591 Filed 4-19-07; 8:45 am]
BILLING CODE 4165-15-P